Monitoring an Informed Consent

So imagine you are a monitor. You have flown hundreds of miles to a site and have finally arrived to begin your first look at the work the site has done on your study. You start with the ICF for the site’s very first subject you pick it up, flip to the last page, it is signed. That’s it you’re done go home. Just kidding! Monitoring an Informed Consent form what are you looking for? You are not only checking to see if the ICF is signed you are also checking to see if each page of the ICF is initialed, if all the pages are present if the correct version of the ICF is signed. Make sure that the ICF signed is in the correct language, for example, if the subject’s primary language is Spanish he or she needs to sign a Spanish consent. Some sites have additional material that they require the subjects to sign this could be a separate HIPPA document which discusses the confidentiality of the medical information. The HIPPA language may or may not already be included in the ICF; you are the monitor you need to know if it is. In California there is a requirement for the subjects to sign a document called the California Bill of Rights. Different states require language in place about HIV and/or Genetic testing and this also needs to be included if required. There needs to be a line for the person consenting the subject to sign as well this could be the Study coordinator or the Principal Investigator or the Sub-Investigator. You need to confirm that the person consenting the subjects has been trained on the protocol and this duty is delegated to them on the delegation of duties log found in the study file notebook at the site. If the subject is a minor the consent form should be signed by a legally authorized representative (LAR). And that is just a little taste of what it is like to be a monitor. -Sara

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4 comments on “Monitoring an Informed Consent”

Thank you for the informative article above. I have found it very enlightening.

I have an interview on 29th October 2013 for a CRA position in an NHS facility and wanted your help/advise please.
(a) What kind of challenging situations have you encountered while monitoring? And how did you overcome them?
(B)What kind of questions might I be asked?
(C) What tips and advice would you give?

Hi Rose,
You will be asked questions pertaining to your experience as a CRA. Such as what are the most common findings at your sites. How to you deal with a difficult PI or SC. I would recommend that you read up on GCP. Make sure that all your answers circle back to you having a strong grasp of GCP.
Good Luck,

I would be interested in how your interview went and what questions they asked you. I’m wanting to make a transition from Scientist to CRA. I currently work for the NHS in Pathology. I was wondering where the CRA position was advertised? I can’t seem to find any on the NHS job website near Birmingham. There a quite a few for Southampton but most are for nursing staff. Any help or advice would be greatly appreciated.
Goodluck for your interview on the 29th October. I’ll be keeping my fingers crossed for you !